Saddle spinal block with low-dose intrathecal morphine for pain after penile inversion vaginoplasty
Official title: The Addition of a Saddle Block With Intrathecal Morphine for Analgesia in Transgender Patients Undergoing Penile Inversion Vaginoplasty: A Randomized Double-blind Placebo-controlled Trial
Run by Women's College Hospital · NCT06556121 · Data updated 2026-11-12
This trial tests whether adding a motor-sparing saddle spinal block with low-dose intrathecal morphine to usual pain care reduces postoperative pain after penile inversion vaginoplasty for transgender women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Men only |
| Enrollment | 40 (estimated) |
| Sponsor | Women's College Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | August 7, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | August 13, 2025 |
| Trial ID | NCT06556121 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are transgender women aged 18–70 undergoing primary penile inversion vaginoplasty who are ASA I–III, can read/speak English, are not chronic high-dose opioid users, and have no contraindication to spinal or local anesthetic techniques.
✕Probably not a fit
Patients on high-dose opioids (over ~30 mg oxycodone-equivalent per day), those with contraindications to spinal or local anesthetics, and those undergoing revision or vulvaplasty are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, placebo-controlled interventional trial at Women's College Hospital comparing the addition of a motor-sparing saddle block with low-dose (100 mcg) intrathecal morphine to standard multimodal analgesia and pudendal nerve block for penile inversion vaginoplasty. The saddle block uses ultra-low dose hyperbaric spinal local anesthetic to target sacral pain fibers while limiting motor effects and rostral opioid spread. Participants are adult patients (ages 18–70) with ASA I–III status undergoing primary penile inversion vaginoplasty. Outcomes include postoperative analgesia, opioid consumption, and opioid-related adverse effects measured in the perioperative period.
Why it matters
Potential benefit: If successful, the intervention could provide stronger and longer-lasting perineal pain relief after surgery while reducing systemic opioid needs and related side effects.
How similar studies have gone: Intrathecal opioids and motor-sparing saddle blocks have shown effective analgesia for abdominopelvic and perineal procedures in prior work, but the specific use of low-dose intrathecal morphine for penile inversion vaginoplasty is largely novel and previously supported mainly by anecdotal experience.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I-III patients * Ages 18-70 years * Penile Inversion Vaginoplasty Exclusion Criteria: * Local infection * History of use of over 30mg oxycodone or equivalent per day. * Contraindication to a component of multi-modal analgesia * Complications or adverse events unrelated to the local anesthetic that precludes evaluation of the primary and secondary outcome measures. * Unable to speak or read English. * Revision and Vulvaplasty surgeries
Where it's running
-
Women's College Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Richard Brull, MD — Women's College Hospital
- Study coordinator: Didem Bozak
- Email: didem.bozak@wchospital.ca
- Phone: 416-323-6008
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.